MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM; PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES

Model Number	9850EV52US
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing and a follow-up report will be submitted when the investigation is complete.
Event or Problem Description
Edwards received notification of an evoque procedure in the tricuspid position where, following valve release, the anterior side appeared to migrate atrially.Tee confirmed atrialization of the anterior valve segment, with native leaflets visualized beneath the device.The patient had a history of significant weight loss (from 95.45 kg to 58.3 kg), prior mechanical mitral valve replacement causing acoustic shadowing, and challenging rv wire placement due to interference from a pacemaker lead and papillary muscle.These procedural factors were present in a case where limited visualization, posterior wire bias, and difficulty achieving depth were observed, and valve malposition occurred.No post-deployment interrogation was performed, as the patient was transitioned to ct surgery for valve removal.On pod 2, the patient returned to surgery for washout and closure after being left open for 48 hours, reportedly due to anticoagulation-related bleeding concerns.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6, and h11.Additional type of investigation codes that were unable to be added in h6: analysis of images.Labeling review.Additional information: an rv gram was taken at the beginning of the procedure prior to wire placement to better visualize the subvalvular anatomy, as the screening ct was not high quality.During the case review, it was clarified that the placement of the wire through a pigtail catheter in the posterior position was the source of most of the procedural issues, as it became entangled in the posterior subvalvular anatomy and held the delivery system posterior throughout the case.Additionally, it was noted that when depth was added, this maneuver did not translate as the nosecone was caught within a chordal structure with the chordal structure tensioned against the guidewire lumen of the delivery system proximal to the nosecone.Therefore, moving anterior and moving ventricular were not possible with the wire placement.The last update regarding the patient status was that as of pod 13 the physician said that the patient was still sick in the icu with slow progress.Based on the complaint investigation, the complaint for malposition - valve embolizes into atrium was confirmed with objective evidence.The device history record review was completed, and this device passed all manufacturing and sterilization inspections.No nonconformances related to the complaint event were identified.The imaging evaluation confirmed that at anchors at 90 degrees, the anterior leaflet was pinned and the device was posterior in position.The clinical specialist noted that this was observed in the case, and that device maneuvers were attempted to move more anterior in position but they were ultimately unsuccessful.The decision was made to continue to flip anchors to then pull the nosecone back to try to gain depth.This maneuver was attempted, however, the device was held posterior in position and depth was not translating.The imaging evaluation revealed that the nosecone was caught within a posterior chordal structure, which prevented the device from moving anterior or ventricular.All maneuvers to move the device anterior and ventricular were exhausted, however these maneuvers were not successful.The decision was made to deploy the valve, despite having four anchors with pinned leaflets (anterior and lateral sides of device).Upon deployment, the nosecone of the delivery system immediately jumped posterior and was challenging to remove from the anatomy, which demonstrates how entangled the nosecone was in posterior chordal structures.Available information suggests that the positioning and methodology of wire placement contributed to the limited translation of device maneuvers, and the resulting lack of leaflet capture of four anchors contributed to the valve embolization.Malposition events such as embolization may be caused by a variety of factors such as device to native anatomy sizing (perimeter-derived diameter), use factors and procedural factors.Since there are no confirmed product or labeling/ifu/training material non-conformances affecting distributed product and no other triggers have been met, no preventative or corrective actions are required.

• Brand Name: EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM
• Common Device Name: PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: cassandra cook ; 1 edwards way; irvine, CA 92614 ; 5743778277
• MDR Report Key: 22142832
• Report Number: 2015691-2025-04409
• Device Sequence Number: 8233343
• Product Code: NPW
• UDI-Device Identifier: 00690103217469
• UDI-Public: (01)00690103217469(17)260708(11)240708
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P230013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 07/08/2026
• Device Model Number: 9850EV52US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female